Status:
COMPLETED
Investigating Loss of Neuromuscular Junction Transmission Fidelity in Older Adults
Lead Sponsor:
NMD Pharma A/S
Collaborating Sponsors:
Ohio University
Ohio State University
Conditions:
Sarcopenia
Eligibility:
All Genders
18+ years
Brief Summary
Sarcopenia is a condition characterised by age-related loss of muscle mass and function. Factors affecting the strength of muscle contraction independent of mass, such as neuromuscular junction (NMJ) ...
Detailed Description
The study is a cross-sectional pilot study and will be led by investigators: 1. Professor Brian Clark, PhD, Ohio University 2. Professor William David Arnold, MD, Ohio State University Up to 16 olde...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Men and women 70+ years of age OR men and women 18-50 years old
- Body mass index between 19 and 40 kg/m2.
- Willingness to undergo all testing procedures, maintain current diet during the study period, and adhere to the study protocol.
- Exclusion Criteria:
- Neuromuscular Disease (ie. movement disorder, or overt neurological disease, such as Sensory Neuropathy with Sensory Ataxia, Apraxia, Post-Polio Syndrome, Mitochondrial Myopathy, Myelopathy, myasthenia gravis)
- Neurological Disease (ie. Dementia (Alzheimers, multi-infarct, fronto-temporal); multiple sclerosis, amyotrophic lateral sclerosis, Parkinsons Disease, cerebellar ataxia, or significant cognitive impairment (a score of 22 or less on the Montreal Cognitive Assessment (MOCA))
- Musculoskeletal disorders (ie. rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, acute gout or osteoarthritis limiting mobility)
- Terminal illness(i.e., Cancer, myeloma, acute leukaemia)
- Uncontrolled Psychiatric disorder (ie. bipolar, schizophrenia, major depression)
- Cardiovascular Diseases (ie. NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, recent history of cardiac arrest, uncontrolled atrial fibrillation, use of a cardiac defibrillator, or uncontrolled angina or hypertension)
- Other significant conditions (ie, that would impact safety and/or compliance to the protocol (e.g. chronic renal failure requiring peritoneal or hemodialysis, chronic liver disease, blood dyscrasia, carcinoma within last 3 years, severe inflammatory bowel disease, severe respiratory disease (uncontrolled asthma, COPD), etc)
- Drug or alcohol abuse
- Not meeting MRI eligibility (e.g. metal implants, reported pregnancy or positive pregnancy test at the time of imaging for women aged 55 years or younger);
- Not meeting the DEXA eligibility (e.g. reported pregnancy or positive pregnancy test at the time of imaging for women aged 55 years or younger);
- Failure to provide informed consent;
- Subjects who do not answer "male" or female" to the question of biological sex
- Currently or recently (within the last 1 year) taking gender affirming hormones.
Exclusion
Key Trial Info
Start Date :
March 16 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 22 2021
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04904926
Start Date
March 16 2021
End Date
September 22 2021
Last Update
November 11 2021
Active Locations (1)
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1
Ohio University
Athens, Ohio, United States, 45701